NordPerMed: The Nordic IBD treatment strategy trial (NORDTREAT)

IBD is a disease entity of unknown origin, characterized by a chronic inflammation in the gastrointestinal tract. IBD is increasing, and today 0.5-1% of the Nordic population is affected. The disease course varies from an indolent to an aggressive, treatment refractory disease, with need of repeated admissions, surgery and risk of comorbidity including cancer. Thus, IBD have severe consequences for many affected individuals, including life-long medication, hospitalizations, recurring sick-leaves, and surgical interventions. The extensive heterogeneity among IBD patients, is a major clinical challenge. Current IBD treatment is expensive and lacks in therapeutic precision, which reduces efficacy and safety and increases the risk of disease progression throughout life. In this project, our aim is to identify patients with a poor prognosis based on a novel objective protein signature, recently identified by members of the NORDTREAT team, and adapt the treatment in these patients to minimize disease-induced damage and to improve long-term disease outcomes. NORDTREAT exploitation plan includes the development of this protein signature into a diagnostic application, implementation of this diagnostic application as a prognostic tool in healthcare and exploration of potential additional novel biomarkers in collaboration with the Nordic biomedical industrial sector and especially biomarker manufacturers. By implementing this personalised medicine strategy, NORDTREAT will reduce societal costs and improve quality of care for patients with IBD. The NORDTREAT intervention study is a Nordic multicentre study. Patients at 14 hospitals in the Nordic region are included, of which four hospitals are in Norway. These are Oslo University Hospital HF, Vestre Viken, Bærum Hospital, Vestfold Hospital and the hospital in Telemark. As of 31st October 2023, 250 out of 300 planned patients are included in the study and we estimate that the inclusion will be completed in December 2023. A further 250 IBD patients and controls have been included in parallel in an observational study. Clinical data and biomaterial from this study will be used for studies on diagnostic and prognostic biomarkers within, among other things, micro- and mycobiota in the gut and markers for fibrosis in blood

The NORDTREAT project will build on the achievements within recent large-scale European initiatives that includes cross-disciplinary collaborations between academia, hospitals, biomedical companies and patient organisations. The overall aim is to improve Inflammatory bowel disease (IBD) patients' prognosis and quality of life by introducing a novel personalized medicine algorithm that is based on recently generated -omics data. IBD is a disease entity of unknown origin, characterized by a chronic inflammation in the gastrointestinal tract. IBD is increasing, and today 0.5-1% of the Nordic population is affected. The disease course varies from an indolent to an aggressive, treatment refractory disease, with need of repeated admissions, surgery and risk of comorbidity including cancer. Thus, IBD have severe consequences for many affected individuals, including life-long medication, hospitalizations, recurring sick-leaves, and surgical interventions. The extensive heterogeneity among IBD patients, is a major clinical challenge. Current IBD treatment is expensive and lacks in therapeutic precision, which reduces efficacy and safety and increases the risk of disease progression throughout life. In this project, our aim is to identify patients with a poor prognosis based on a novel objective protein signature, recently identified by members of the NORDTREAT team, and adapt the treatment in these patients to minimize disease-induced damage and to improve long-term disease outcomes. NORDTREAT exploitation plan includes the development of this protein signature into a diagnostic application, implementation of this diagnostic application as a prognostic tool in healthcare and exploration of potential additional novel biomarkers in collaboration with the Nordic biomedical industrial sector and especially biomarker manufacturers. By implementing this personalised medicine strategy, NORDTREAT will reduce societal costs and improve quality of care for patients with IBD.